Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 11: Capillary Electrophoresis General Chapter

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Guidance for Industry
Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the
ICH Regions
Annex 11
Capillary Electrophoresis
General Chapter
U. S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
September 2010
ICH

Guidance for Industry
Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the
ICH Regions
Annex 11
Capillary Electrophoresis
General Chapter
Additional copies are available from:
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Center for Drug Evaluation and Research
Food and Drug Administration
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Phone: 301-796-3400; Fax: 301-847-8714; E-mail: druginfo@fda.hhs.gov
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
or
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(Tel) 800-835-4709 or 301-827-1800
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
September 2010
ICH

TABLE OF CONTENTS
I. 	INTRODUCTION (1)....................................................................................................... 1
II. 	Q4B OUTCOME (2) ......................................................................................................... 2
A. 	Analytical Procedures (2.1) ........................................................................................................... 2
B. 	Acceptance Criteria (2.2)............................................................................................................... 2
III. 	TIMING OF ANNEX IMPLEMENTATION (3) .......................................................... 2
IV. 	CONSIDERATIONS FOR IMPLEMENTATION (4).................................................. 2
A. 	General Consideration (4.1).......................................................................................................... 2
B. 	FDA Consideration (4.2) ............................................................................................................... 2
C. 	EU Consideration (4.3) .................................................................................................................. 3
D. 	MHLW Consideration (4.4) .......................................................................................................... 3
E. 	Health Canada Consideration (4.5).............................................................................................. 3
V. 	REFERENCES USED FOR THE Q4B EVALUATION (5) ........................................ 3
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Contains Nonbinding Recommendations
Guidance for Industry1
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the ICH Regions
Annex 11
Capillary Electrophoresis General Chapter
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate
number listed on the title page of this guidance.
I. 	INTRODUCTION (1)2
This annex is one in a series of guidance documents that describe the evaluations and
recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts
to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH
regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry.
For general information on the Q4B process, the reader is referred to the core guidance Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.3
This annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
1 This guidance was developed within the Expert Working Group (Quality) of the International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been
subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been
endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2010. At Step 4 of the process, the final
draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States.
2 Arabic numbers reflect the organizational breakdown of the document endorsed by the ICH Steering Committee at
Step 4 of the ICH process, June 2010.
3We update guidance documents periodically. To make sure you have the most recent version of a guidance, check
the FDA Drugs guidance page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm or the FDA Biologics guidance page at
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
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Contains Nonbinding Recommendations
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
II. 	Q4B OUTCOME (2)
A. 	Analytical Procedures (2.1)
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group
(EWG), recommends that the analytical procedures described in the official pharmacopoeial
texts, Ph. Eur. 2.2.47. Capillary Electrophoresis, JP General Information 4. Capillary
Electrophoresis, and USP General Information Chapter <1053> Biotechnology-derived Articles
– Capillary Electrophoresis,4 can be used as interchangeable in the ICH regions.
B. 	Acceptance Criteria (2.2)
The texts evaluated did not contain acceptance criteria.
III. 	TIMING OF ANNEX IMPLEMENTATION (3)
When this annex is implemented (incorporated into the regulatory process at ICH Step 5) in a
region, it can be used in that region. Timing might differ for each region.
IV. 	CONSIDERATIONS FOR IMPLEMENTATION (4)
A. 	General Consideration (4.1)
When sponsors or manufacturers change their existing methods to the implemented Q4B-
evaluated pharmacopoeial texts that are referenced in section II.A (2.1) of this annex, any change
notification, variation, and/or prior approval procedures should be handled in accordance with
established regional regulatory mechanisms pertaining to compendial changes.
B. 	FDA Consideration (4.2)
Based on the recommendation above, and with reference to the conditions set forth in this annex,
the pharmacopoeial texts referenced in section II.A (2.1) of this annex can be considered
interchangeable. However, FDA might request that a company demonstrate that the chosen
4 The harmonized text under review has been incorporated into USP informational chapter <1053> Biotechnology-
derived Articles – Capillary Electrophoresis, which is official (as of the July 1, 2009, USP Revision Bulletin). The
USP proposed in Pharmacopeial Forum (Vol. 36, number 1) to drop the existing (mandatory) General Chapter
<727> Capillary Electrophoresis (also now official), and rename the (nonmandatory) chapter <1053> to Capillary
Electrophoresis. The official date for this change will be May 1, 2011 (USP 34-NF29).
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Contains Nonbinding Recommendations
method is acceptable and suitable for a specific material or product, irrespective of the origin of
the method.
C. 	EU Consideration (4.3)
For the European Union, regulatory authorities can accept the reference in a marketing
authorization application, renewal or variation application citing the use of the corresponding
text from another pharmacopoeia as referenced in section II.A (2.1), in accordance with the
conditions set out in this annex, as fulfilling the requirements for compliance with the Ph. Eur.
Chapter 2.2.47. on the basis of the declaration of interchangeability made above.
D. 	MHLW Consideration (4.4)
The pharmacopoeial texts referenced in section II.A (2.1) of this annex can be used as
interchangeable in accordance with the conditions set out in this annex. Details of
implementation requirements will be provided in the notification by MHLW when this annex is
implemented.
E. 	Health Canada Consideration (4.5)
In Canada, any of the texts cited in section II.A (2.1) of this annex and used in accordance with
the conditions set out in this annex can be considered interchangeable.
V. 	REFERENCES USED FOR THE Q4B EVALUATION (5)
A. (5.1) The PDG Stage 5B sign-off document: Japanese Pharmacopoeial Forum,
Volume 11, number 4 (October 2002).
B. (5.2) The pharmacopoeial references for Capillary Electrophoresis General Chapter
for this annex are:
1. (5.2.1) 	European Pharmacopoeia (Ph. Eur.): Supplement 6.6 (published June
2009, and official January 1, 2010), Capillary Electrophoresis (reference
01/2008:20247).
2. (5.2.2) 	Japanese Pharmacopoeia (JP): General Information 4. as it appears in
the JP Fifteenth Edition (March 31, 2006, The Ministry of Health, Labour and
Welfare Ministerial Notification No. 285). The English text was officially updated
by errata published by MHLW at
http://www.std.pmda.go.jp/jpPUB/Data/ENG/jpdata/H201105_jp15_errata.pdf on
May 28, 2010.
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Contains Nonbinding Recommendations
3. (5.2.3) 	United States Pharmacopeia (USP):5 <1053> Biotechnology-derived
Articles – Capillary Electrophoresis, USP Revision Bulletin posted May 29, 2009,
official July 1, 2009.
See footnote 4.
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